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OSTEOPAL® V bone cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a vertebroplasty or balloon kyphoplasty procedure.

OSTEOPAL® V is a PMMA bone cement for use in vertebroplasty. It is formed from powder and liquid by exothermic polymerization.

This document is a 510(k) premarket notification for a medical device called OSTEOPAL® V, which is a polymethylmethacrylate (PMMA) bone cement. The purpose of the submission is to gain clearance for modifications to an existing device (K050085). Based on the provided text, the device itself is a material (bone cement), and thus the acceptance criteria and study described are for the performance of the material, not for an AI/software device. Therefore, many of the requested fields are not applicable.

Here's the information derived from the provided document regarding the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily discusses non-clinical testing for material properties and risk assessments. There is no mention of a "test set" in the context of patient data or clinical imaging. The studies performed are mechanical testing, stability testing, and risk assessments. For these non-clinical tests, specific sample sizes are not provided in this summary. The data provenance is implied to be from Heraeus Medical GmbH in Germany, where the device is manufactured and where the tests would typically be performed. The tests are prospective in nature (i.e., new tests performed on the modified device).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as there is no "test set" or "ground truth" related to expert opinions on medical images or diagnoses for this device. The evaluation is based on engineering standards, material science, and risk assessment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable as there is no "test set" requiring adjudication by experts.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. OSTEOPAL® V is a bone cement, not an AI/software device, and no MRMC study with human readers assisting with AI was performed or is relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. OSTEOPAL® V is a bone cement, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For the non-clinical tests (mechanical, stability, material characterization), the "ground truth" is established by adherence to recognized international standards (e.g., ISO 5833, ASTM F451, DIN EN ISO 14971) and validated laboratory testing methodologies. For the MR safety assessment, the "ground truth" is based on the material properties and scientific rationale. For the labeling and risk assessments, the "ground truth" is derived from clinical evaluations of the device's performance in the field (implicitly from the predicate device's history and relevant medical literature), coupled with the risk assessment process. There is no specific "expert consensus" or "pathology" ground truth mentioned as would be relevant for a diagnostic device.

8. The sample size for the training set

This is not applicable as there is no "training set" for an AI/software model. The device is a physical product (bone cement).

9. How the ground truth for the training set was established

This is not applicable as there is no "training set."

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COPAL® exchange G hip spacer (polymethy)methacrylate / gentamicin) is indicated for temporary use (maximum of 180 days) as a total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. The device is inserted into the femoral medullary canal and acetabular cavity following removal of the existing implant and radical debridement. The device is assigned to be used in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). COPAL® exchange G hip spacer is not intended for use for more than 180 days, at which time it must be explanted, and a permanent device implanted, or another appropriate treatment performed (e.g., resection arthroplasty, fusion etc.). COPAL® exchange G hip spacer is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers, canes) throughout the implantation period.

COPAL® G+V (gentamicin and vancomycin) is a PMMA bone cement intended for fixation of COPAL® exchange G hip spacer to the host bone.

COPAL® exchange G hip spacer is a temporary hip spacer implant as part of two-stage septic endoprosthesis revision based on bone cement. COPAL® exchange G hip spacer contains gentamicin. Gentamicin reduces the risk for bacterial colonization of the device and is released into the fluid surrounding the joint. COPAL® exchange G hip spacer is intended for single-use and is supplied sterile.

COPAL® exchange G hip spacer is made of fully formed polymethyImethacrylate (radiopaque PMMA with gentamicin) and contains an inner stainless steel (AISI 316L) reinforcing structure. The mass used in the filling of the molds (the PMMA unformed resin) is prepared from a powder component and a liquid component. It contains the X-ray contrast medium carbonate. To improve visibility in the surgical field, it has been colored with chlorophyll-copper-complex (E141).

COPAL® G+V is a standard-setting, high-viscosity, radiopaque, poly(methy) methacrylate)-based (PMMA) bone cement, containing gentamicin and vancomycin, designed for fixation of COPAL® exchange G hip spacer to the host bone. COPAL® G+V is intended for single-use and is supplied sterile.

The provided text is a 510(k) summary for the COPAL® exchange G hip spacer and COPAL® G+V. It describes the device, its intended use, and the testing performed to demonstrate substantial equivalence to a predicate device.

However, the document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/algorithm-driven medical device. The section "VII. PERFORMANCE DATA" primarily focuses on mechanical testing, biocompatibility, packaging, sterilization, and shelf life for a physical medical device (hip spacer and bone cement). It also mentions a "Clinical evaluation" but clarifies it was to "analyze the existing clinical data of predicate device and legally marketed U.S. devices" and "no unknown complications that have not yet been described in the instructions for use were found." Crucially, it explicitly states, "No clinical tests were performed to demonstrate substantial equivalence."

Therefore, I cannot extract the information required to answer your prompt, as the prompt's assumptions (acceptance criteria, test set, ground truth, MRMC study, standalone performance for an algorithm) are not applicable to the content of this 510(k) summary for a physical orthopedic device.

If you have a document describing an AI/algorithm-driven medical device and its performance studies, please provide that document, and I will be happy to attempt to extract the requested information.

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COPAL® knee moulds are designed to prepare spacers by filling the moulds with bone cement. COPAL® knee moulds are disposable cement spacer mold a temporary total knee replacement (TKR) for skeletally mature patients undergoing a two-stage procedure due to a septic process. The molded temporary knee spacer is indicated for an implantation period of 180 days or less. Because of inherent mechanical limitations of the device material (PALACOS® R+G bone cement), the molded temporary spacer is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers) throughout the implant period.

COPAL® knee moulds are sterile single-use moulds used for the preparation of spacers that are intended as temporary knee replacements as part of two-stage septic joint prosthesis revision.

COPAL® knee moulds comprise a tibial component and a femoral component, which together form a bearing and move aqainst one another. They can be used in both the right and the left knee joint. The spacer function provides that after removal of the prosthesis the existing joint space is retained and contraction of the musculature and the surrounding tissues is prevented.

COPAL® knee moulds are intended for single use and must not be re-used or resterilised.

The provided text does not describe a study involving an AI/Machine Learning (ML) device, but rather a traditional medical device (COPAL® knee moulds). Therefore, many of the requested categories related to AI/ML device performance and testing (e.g., ground truth, MRMC studies, effect size of AI assistance, training set information) are not applicable.

Here's an analysis of the provided information based on the request:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify sample sizes for the mechanical, functional, or biocompatibility tests. It also does not provide details on the data provenance in terms of country of origin or whether studies were retrospective or prospective, as these are typically not detailed in 510(k) summaries for this type of device. The studies are laboratory-based tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is a physical medical device, not an AI/ML diagnostic tool requiring expert ground truth for image interpretation or similar tasks. The "ground truth" here refers to established scientific and engineering standards and validated testing methodologies.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not a study requiring adjudication of expert opinions for a test set. Acceptance criteria are based on objective, standardized laboratory test results.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is not an AI-assisted diagnostic tool, so no MRMC study or assessment of human reader improvement with AI assistance was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the performance of the COPAL® knee moulds is established by adherence to recognized international and FDA standards for biocompatibility (ISO 10993-1), sterilization (ISO 11135), and general mechanical and functional performance relevant to medical devices of this type. This involves objective measurements against predefined thresholds and specifications, not expert consensus on interpretations.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This device is not an AI/ML algorithm.

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COPAL® exchange G hip spacer (polymethylmethacrylate / gentamicin) is indicated for temporary use (maximum of 180 days) as a total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. The device is inserted into the femoral medullary canal and acetabular cavity following removal of the existing implant and radical debridement. The device is assigned to be used in conjunction with systemic antibiotic therapy (standard treatment approach to an infection). COPAL® exchange G hip spacer is not intended for use for more than 180 days, at which time it must be explanted, and a permanent device implanted, or another appropriate treatment performed (e.g., resection arthroplasty, fusion etc.). COPAL® exchange G hip spacer is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, canes) throughout the implantation period.

COPAL® exchange G hip spacer is a temporary hip spacer implant as part of two-stage septic endoprosthesis revision based on bone cement. COPAL® exchange G hip spacer contains gentamicin. Gentamicin reduces the risk for bacterial colonization of the device and is released into the fluid surrounding the joint. COPAL® exchange G hip spacer is intended for single-use and is supplied sterile.

COPAL® exchange G hip spacer is made of fully formed polymethylmethacrylate (radiopaque PMMA with gentamicin) and contains an inner stainless steel (AISI 316L) reinforcing structure. The mass used in the filling of the molds (the PMMA unformed resin) is prepared from a powder component and a liguid component. It contains the X-ray contrast medium carbonate. To improve visibility in the surgical field, it has been colored with chlorophyll-copper-complex (E141).

COPAL® exchange G hip spacer will be used with COPAL® exchange G hip trials (510(k) exempt devices).

This response analyzes FDA K220492 for "COPAL® exchange G hip spacer." It is important to note that this device is a physical medical implant, not an AI/ML powered software device. Therefore, many of the requested criteria related to AI/ML device testing (e.g., ground truth establishment, expert adjudication, MRMC studies) are not applicable to this submission.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a physical medical device (hip spacer) and not an AI/ML powered device, the "acceptance criteria" are not based on metrics like accuracy, sensitivity, or specificity. Instead, they relate to mechanical performance, material properties, and biocompatibility. The provided document indicates that the acceptance criteria for the modified device were the same as those for the original predicate device (K191016).

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not applicable in the context of an AI/ML test set. For physical device testing, the sample size would refer to the number of devices or components tested. The document does not specify the exact number of spacers tested for fatigue or endotoxin, but states that "COPAL® exchange G hip spacer meets endotoxin limits" and "The fatigue performance testing as per ISO 7206-6 was performed... The acceptance criteria were not altered...". This implies that standard testing was conducted on an appropriate number of samples to demonstrate compliance.
• Data Provenance: Not applicable in the context of clinical data for AI/ML. The performance data is generated from laboratory mechanical and material testing. The document states the manufacturer is Heraeus Medical GmbH, located in Germany, implying the testing was conducted under their control.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable. For a physical device, "ground truth" is established by engineering specifications, material standards, and validated testing methodologies, not by expert consensus on clinical images or patient data.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical data for AI/ML models.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. This device is a physical implant, not a diagnostic AI tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical device, so there is no "algorithm only" performance to evaluate.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on engineering specifications, international standards (e.g., ISO 7206-6, DIN EN ISO 14971), and validated laboratory testing results for mechanical properties (fatigue), material composition, and biological safety (endotoxin).

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML model, so there is no training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there's no AI/ML model, there's no training set or ground truth establishment for it.

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PALACOS® MV pro is indicated for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.

PALACOS® MV pro is a standard-setting, medium viscosity, radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). It contains the X-ray contrast medium zirconium dioxide. To improve visibility in the surgical field, it has been colored with chlorophyllcopper-complex (E141). The bone cement consists of two components and is prepared immediately before use by mixing the polymer powder) with the monomer liquid (= liquid). A ductile dough forms that sets within a few minutes.

The provided text describes a 510(k) premarket notification for a medical device called PALACOS® MV pro, a polymethylmethacrylate (PMMA) bone cement. This submission aims to demonstrate substantial equivalence to a legally marketed predicate device.

The information provided does not describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of an AI/ML powered device, or any diagnostic device subject to performance metrics like sensitivity, specificity, AUC, etc. Instead, it focuses on demonstrating substantial equivalence to a predicate device, which is a different regulatory pathway.

Therefore, many of the requested items (e.g., performance metrics, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance) are not applicable or mentioned in this document.

Here's an analysis based on the information provided in the document:

1. A table of acceptance criteria and the reported device performance:

The document doesn't explicitly state acceptance criteria in terms of specific numerical thresholds for performance metrics commonly associated with AI/ML or diagnostic devices (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" for demonstrating substantial equivalence are based on matching the predicate device's intended use, technological characteristics, and operating principle. The "reported device performance" is demonstrated through various tests designed to show that the subject device functions as intended and is safe and effective, aligning with the predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Test Set Sample Size: Not applicable in the context of an AI/ML test set. The document refers to various engineering and biological tests conducted on the device itself or representative materials. The 'sample size' for these tests would refer to the number of units tested, but this is not specified for each test.
• Data Provenance: Not applicable in the context of an AI/ML test set. The tests are laboratory-based and follow international standards. The manufacturer is Heraeus Medical GmbH, located in Germany.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. This is not a diagnostic device or an AI/ML system requiring expert-established ground truth for a test set. The "ground truth" for this device's performance is established through adherence to recognized international standards and laboratory testing for physical, mechanical, chemical, and biological properties.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. There is no expert adjudication process described, as it's not relevant for this type of device and submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is a bone cement, not an AI-assisted diagnostic tool. No MRMC study was performed or is relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a PMMA bone cement, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The "ground truth" for this device's safety and effectiveness, in the context of substantial equivalence, is rooted in:

• International Standards: Adherence to established mechanical (ISO 5833, ASTM F451), sterilization (ISO 11135), biocompatibility (ISO 10993-1), and pyrogenicity (ANSI/AAMI ST72) standards.
• Predicate Device Performance: The demonstrated safe and effective use of the predicate device (PALACOS® R pro) acts as a benchmark. The subject device is shown to be equivalent in its properties to this predicate.
• Laboratory Testing Results: Direct measurements of physical, chemical, and biological properties in controlled laboratory settings.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device, so there is no "training set."

9. How the ground truth for the training set was established:

Not applicable. There is no "training set" or associated ground truth establishment process for this device as it is not an AI/ML product.

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PALACOS® R pro is indicated for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.
PALACOS® R+G pro is indicated for use in the second stage revision for total joint arthroplasty after the initial infection has been cleared.
PALACOS® MV+G pro is indicated for use in the second stage revision for total joint arthroplasty after the initial infection has been cleared.

PALACOS® R pro is a standard-setting, high-viscosity, radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). It contains the X-ray contrast medium zirconium dioxide. To improve visibility in the surgical field, it has been colored with chlorophyll-copper-complex (E141). The bone cement consists of two components and is prepared immediately before use by mixing the polymer powder (= powder) with the monomer liquid (= liquid). A ductile dough forms that sets within a few minutes.
PALACOS® R+G pro is a standard-setting, high-viscosity, radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). It contains the aminoglycoside antibiotic gentamicin to protect the cured bone cement and contiguous tissue against colonization by bacteria that are sensitive to gentamicin. It contains the X-ray contrast medium dioxide. To improve visibility in the surgical field, it has been colored with chlorophyll-copper-complex (E141). The bone cement consists of two components and is prepared immediately before use by mixing the polymer powder (= powder) with the monomer liquid (= liquid). A ductile dough forms that sets within a few minutes.
PALACOS® MV+G pro is a standard-setting, medium viscosity, radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). It contains the aminoglycoside antibiotic gentamicin to protect the cured bone cement and contiguous tissue against colonization by bacteria that are sensitive to gentamicin. It contains the X-ray contrast medium zirconium dioxide. To improve visibility in the surgical field, it has been colored with chlorophyll-copper-complex (E141). The bone cement consists of two components and is prepared immediately before use by mixing the polymer powder (= powder) with the monomer liquid). A ductile dough forms that sets within a few minutes.

This FDA 510(k) Premarket Notification is for PALACOS® R pro, PALACOS® R+G pro, and PALACOS® MV+G pro bone cements. It does not describe an AI/ML device, a clinical study with human readers, or a ground truth established by experts. Instead, it focuses on demonstrating substantial equivalence to previously cleared predicate devices through non-clinical performance testing.

Here's a breakdown based on the provided document:

1. A table of acceptance criteria and the reported device performance

The document does not present a formal table of acceptance criteria with reported numerical performance values in the way you might expect for an AI device (e.g., sensitivity, specificity, AUC). Instead, it states that the devices meet existing industry standards and guidance documents. The "acceptance criteria" are implied by adherence to these standards, and the "reported performance" is that the devices meet them.

• Concluded that possible transfer of leachables is low.
• Cytotoxicity test performed to support this conclusion.
• No negative impact estimated from changes. |
  | Mechanical & Functional | FDA Guidance document Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement - Guidance for Industry and FDA (July 17, 2002) (Annex I and Annex II) | - Tests conducted to demonstrate intended function, safety, and effectiveness.
• Data provided to state substantial equivalence to predicate device. |
  | Sterilization | ISO 11135 | - Validation performed using ethylene oxide gassing.
• Cycle designed for sterile units with a sterility assurance level (SAL) of 10⁻⁶.
• Chosen sterilization process considered valid, showing equivalence to predicate device. |
  | Pyrogenicity | ANSI/AAMI ST72 (LAL test) | - Subject device meets endotoxin limit specification of ≤ 20 EU/device.
• Shows equivalence to predicate device. |

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This document details non-clinical laboratory testing, not a test set of patient data. Therefore, the concepts of "sample size used for the test set" and "data provenance (country of origin, retrospective/prospective)" as they relate to patient data or imagery do not apply. The testing was conducted in a laboratory setting, likely in Germany where the manufacturer is located, or by authorized testing facilities.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The ground truth for this type of device (bone cement) is not established by human experts in the context of medical image interpretation. The "truth" is determined by established physical, chemical, and biological testing standards and measurements.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. There is no human adjudication process described, as the testing is based on objective laboratory measurements against defined standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this submission is based on:

• Established objective standards: International Standards (e.g., ISO 10993-1, ISO 11135, ANSI/AAMI ST72) and FDA Guidance documents (e.g., "Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement").
• Laboratory measurements: Results from specific tests (cytotoxicity, mechanical property measurements, sterility assurance level determination, LAL test for endotoxins) designed to objectively evaluate the device's conformance to these standards and demonstrate substantial equivalence to predicate devices.
• Chemical and material analysis: Confirmation of identical (or acceptably different) chemical composition and materials compared to predicate devices.

8. The sample size for the training set

Not applicable. This is not a machine learning device and therefore does not have a "training set" in that context.

9. How the ground truth for the training set was established

Not applicable. As above, there is no "training set" for this type of device.

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PALACOS® R is indicated for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.

PALACOS® R pro is indicated for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.

PALACOS® R+G is indicated for use in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.

PALACOS® R+G pro is indicated for use in the second stage revision for total joint arthroplasty after the initial infection has been cleared.

PALACOS® MV+G is indicated for use in the second stage revision for total joint arthroplasty after the initial infection has been cleared.

A bundled Traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance for modifications to PALACOS® R, PALACOS® R pro, PALACOS® R+G, PALACOS® R+G pro, and PALACOS® MV+G previously cleared in K030902, K150119, K031673, K142157 and K050855.

Modifications include changes of instructions for use (IFU) and labels as well as the addition of MRI safety information.

This submission encompasses multiple devices that have similar intended use and indications for use as well as rely on similar data.

PALACOS® bone cements without Gentamicin:
PALACOS® R and PALACOS® R pro are polymethylmethacrylate (PMMA) bone cements.
PALACOS® R: is a standard-setting, high-viscosity, PMMA-based bone cement for orthopaedic surgery.
PALACOS® R pro: is a PMMA based PALACOS® R bone cement, packed in a closed mixing and application system ready for processing (ready-to-mix).
The bone cements consist of two components, a monomer liquid and a polymer powder. The liquid component contains the monomer, accelerator, and a stabilizer. The powder contains the polymer, X-Ray-opacifier, and initiator. They are intended for single-use and are provided sterile (ethylene oxide and sterile filtration).

PALACOS® bone cements with Gentamicin:
PALACOS® R+G, PALACOS® R+G pro and PALACOS® MV+G are PMMA bone cements, containing the antibiotic Gentamicin.
PALACOS® R+G (previously cleared under the name PALACOS® G); is a standard-setting. high-viscosity, PMMA-based bone cement for orthopaedic surgery.
PALACOS® R+G pro is a PMMA based PALACOS® R+G bone cement, packed in a closed mixing and application system ready for processing (ready-to-mix) and
PALACOS® MV+G (previously cleared under the name PALAMED G) is a standard-setting, medium-viscosity, radiopaque, poly(methyl methacrylate)-based bone cement for orthopaedic surgery.
The bone cements consist of two components, a monomer liquid and a polymer powder. The liquid component contains the monomer, accelerator, and a stabilizer. The powder contains the polymer, X-Ray-opacifier, initiator and the antibiotic Gentamicin. They are intended for single-use and are provided sterile (ethylene oxide and sterile filtration).

The provided document is a 510(k) premarket notification for PMMA bone cements (PALACOS® R, PALACOS® R pro, PALACOS® R+G, PALACOS® R+G pro, and PALACOS® MV+G). This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than establishing new acceptance criteria or conducting a clinical study to prove device performance against specific metrics.

Therefore, the document does not contain the information requested regarding acceptance criteria, a study proving the device meets those criteria, sample sizes for test/training sets, data provenance, number or qualifications of experts for ground truth, adjudication methods, MRMC studies, standalone performance studies, or how ground truth was established for training sets.

Instead, the document states:

"A risk-based assessment was performed as per DIN EN ISO 14971 to evaluate the impact of the modifications to the labelling... The modified IFUs do not alter the previously validated packaging or sterilization data as well as the existing results of non-clinical performance testing and biocompatibility in accordance with the FDA Class II Special Controls Guidance Document 'PMMA Bone Cement'. The risk-based assessment concludes that the IFU changes do not significantly affect the device's risk profile because no new risks or significantly modified existing risks are identifically based rationale has been prepared to designate the bone cements as "MR Safe"."

And, for each device: "No clinical testing... has been conducted."

The substantial equivalence determination is based on a comparison of technological characteristics with predicate devices, confirming that the subject devices are modified versions with no significant changes to their safety or effectiveness.

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COPAL® exchange G knee (polymethylmethacrylate/gentamicin) is indicated for temporary use (maximum of 180 days) as a total knee replacement (TKR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. COPAL® exchange G knee is applied on the femoral condyles and on the tibial plate following removal of the existing implant and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).

COPAL® exchange G knee is not intended for use for more than 180 days, at which time it must be explanted, and a permanent device implanted, or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.). COPAL® exchange G knee is only indicated for patientswho will consistently use traditional mobility assist devices e.g. crutches, walkers, canes) throughout the implantation period.

COPAL® exchange G hip (polymethylmethacrylate / gentamicin) is indicated for temporary use (maximum of 180 days) as a total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. The device is inserted into the femoral medullary canal and acetabular cavity following removal of the existing implant and radical debridement. The device is assigned to be used in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). COPAL® exchange G hip is not intended for use for more than 180 days, at which time it must be explanted, and a permanent device implanted, or another appropriate treatment performed (e.g., resection arthroplasty, fusion, perm etc.). COPAL®exchange G hip is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers, canes) throughout the implantation period.

The COPAL® exchange G Hip and Knee Spacers are combination products that provide patients, undergoing a two-stage revision procedure for an infected total joint, a temporary implant to 1) allow for partial weight bearing and 2) provide an approximate natural range of motion. The devices also maintain a patient's soft tissue and joint space, preventing further complications such as muscular contraction. The gentamicin protects the device from bacterial colonization.

The COPAL® exchange G Hip and Knee Spacers are placed into the joint to maintain normal joint space and alignment. They provide patient comfort and limited mobility while the infection is being treated. The COPAL® exchange G Hip and Knee Spacers are made with bone cement that are loaded with gentamicin antibiotics. The COPAL® exchange G Hip and Knee Spacers are temporary joint prostheses designed to temporarily replace an infected implant during a total hip or knee arthroplasty and provide the patient with limited mobility and predictable, consistent local antibiotic release

COPAL® exchange G Hip Spacer is a single use device that mimics a hemi-hip prosthesis and is available in 8 sizes and usable for both left and right hips.

The COPAL® exchange G Hip Spacers are combination products made of fully formed polymethylmethacrylate (radiopaque PMMA with gentamicin). The COPAL® exchange G Hip Spacers contain an inner stainless steel (AISI 316L stainless steel) reinforcing structure. The mass used in the filling of the molds (the PMMA unformed resin) is prepared from a powder component and a liquid component. The liquid component consists of methyl methacrylate, N, N-dimethyl-p-toluidine, hydroquinone. The powder component consists of polymethymethacrylate, calcium carbonite, benzoyl peroxide, and gentamicin sulphate. The raw materials and a summary of the manufacturing process are found below.

COPAL® exchange G Knee Spacer is a single use device that is comprised of a tibia and femur component and is available in 3 sizes to form one knee spacer that is usable for left and right knee.

The provided text describes a 510(k) premarket notification for Heraeus Medical GmbH's COPAL® exchange G Hip and Knee Spacers. The document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo clinical performance with specific acceptance criteria that an AI/ML device would typically face.

Due to the nature of this submission (510(k) for a physical medical device, not an AI/ML algorithm), the information required for filling out the requested table regarding acceptance criteria and performance of an "AI/ML device" is largely not applicable or not present in the document. The performance testing section refers to physical and biological tests, not AI model metrics.

However, I will extract what is available and clearly state what information is missing based on your request.

Here's an attempt to address your request based solely on the provided text, while making the critical distinction that this document does not pertain to an AI/ML device:

Acceptance Criteria and Study for COPAL® exchange G Hip and Knee Spacers (as described in K191016)

Note: The provided document describes the 510(k) clearance for physical medical devices (hip and knee spacers) and not an Artificial Intelligence/Machine Learning (AI/ML) device. Therefore, the typical acceptance criteria and study design elements requested for an AI/ML device (e.g., sensitivity, specificity, expert ground truth, MRMC studies, training/test sets) are not relevant or present in this submission. The "acceptance criteria" for this device are demonstrated through equivalence to predicate devices via various physical, chemical, and biological performance testing, not through AI/ML performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

• Irritation: No signs of irritation; classified as not irritant.
• Delayed-type hypersensitivity: No reactions identified as sensitization.
• Acute systemic toxicity: No acute systemic toxic characteristics.
• Reverse mutation assay: Non-mutagenic.
• In vitro mammalian cell gene mutation assay: Non-mutagenic.
• Femoral bone implantation/subchronic systemic toxicity: No inflammatory or degenerative findings at implantation sites.
• Summary: COPAL® exchange G spacers are biocompatible according to ISO10993-2016. |
  | Sterilization Validation | Sterility Assurance Level (SAL) of 10-6 according to ISO 11135 and AAMI TIR 28. | Chosen sterilization process (ethylene oxide gassing) is valid; sterile units achieved with defined bioburden and SAL of 10-6. |
  | Shelf Life | Maintain sterility (DIN EN ISO 11737. Part 2), compressive strength (ISO 7206-6 and ISO 14879-1), gentamicin content, and gentamicin impurities over 36 months at 25 ± 2 °C. | All hip/knee spacers sterile throughout 36-month storage. Compressive strength within specified range. Gentamicin content and impurities remained within specified range.
  Summary: Stable at 25 ± 2 °C and 50% humidity for 36 months. |
  | Sterile Barrier Integrity | Adherence to ISO 11607-1 and ISO 11607-2, including maintenance over 5 years of transport and shelf life. | Integrity of the system shown; maintenance of sterile barrier system demonstrated over 5 years. |
  | Mechanical Performance | Compressive strength (ISO 14879-1, ISO 7206-4, ISO 7206-6), cyclic fatigue (ISO 14879-1, ISO 14242-1:2012), abrasion (ISO 14243-1:2009, ISO 14242-1:2012) demonstrating equivalence to predicate devices. | - Compressive strength: Equivalent to predicate devices.
• Cyclic fatigue: Equivalent to predicate devices.
• Abrasion: Equivalent to predicate devices. |

2. Sample Size Used for the Test Set and Data Provenance

Due to the nature of the device (physical implant, not software/AI):

• Sample Size for Test Set: This concept doesn't directly apply in the "AI/ML" sense of a data test set. The document refers to "tests performed" and "results obtained" for various physical and biological properties. Specific quantitative sample sizes for each test (e.g., number of hip spacers tested for compressive strength) are not provided in this summary.
• Data Provenance: Not applicable in the context of an AI/ML algorithm (e.g., country of origin of patient data). The testing data is generated in a lab setting through physical and chemical tests on the manufactured devices. The document implies these tests were conducted by the manufacturer (Heraeus Medical GmbH, Germany).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

• This is not applicable for this type of device submission. Ground truth, in the AI/ML context, refers to expert labeling of data (e.g., images). For this physical device, "ground truth" is established by adherence to recognized international standards and laboratory testing protocols performed by qualified professionals in those fields (e.g., materials science, microbiology, mechanical engineering). The specific number or qualifications of these testing personnel are not detailed in the summary.

4. Adjudication Method for the Test Set

• This is not applicable for this type of device submission. Adjudication, in the AI/ML context, is typically used for resolving disagreements among multiple human annotators during ground truth establishment. For a physical device, passing/failing criteria are set by the established standards and internal quality control.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• This is not applicable as the device is not an AI/ML algorithm intended to assist human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

• This is not applicable as the device is not an AI/ML algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for these physical devices is established by compliance with recognized international standards (e.g., ISO, ASTM) for material properties (e.g., mechanical strength, chemical composition), biological interactions (biocompatibility), and manufacturing processes (sterilization, shelf life). The "outcome data" is whether the device meets these pre-defined physical and biological performance specifications and demonstrates equivalence to the predicate device.

8. The Sample Size for the Training Set

• This is not applicable as the device is not an AI/ML algorithm. There is no concept of a "training set" in this context. The product is manufactured based on design specifications and then tested for performance.

9. How the Ground Truth for the Training Set was Established

• This is not applicable as the device is not an AI/ML algorithm.

In conclusion, the provided FDA 510(k) submission is for a physical medical device (hip and knee spacers) and not for an AI/ML-based device. Therefore, the requested information regarding AI/ML-specific acceptance criteria, study methodologies (e.g., human-in-the-loop, standalone, MRMC), and data sets (training, test, ground truth establishment) is largely irrelevant to this document. The document primarily focuses on demonstrating substantial equivalence through various physical, chemical, and biological performances tests against established standards and predicate devices.

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PALACOS® fast R+G is indicated for use as bone cement in arthroplasty procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstruction is necessary. The cement is indicated for use in the second stage of a two stage revision for total joint arthroplasty after the initial infection has been cleared.

PALACOS® fast R+G is an acrylic bone cement for use in orthopedic surgery. It is formed from powder and liquid by exothermic polymerization. It secures the fixation of the grafted artificial joint improving the transfer of forces at the interface implant - bone. The antibiotic gentamicin sulphate has been added to protect the cured cement and contiguous tissue against contamination by microbes sensitive to gentamicin. PALACOS® fast R+G is available in 51 g packaging size.

The provided text describes the 510(k) premarket notification for a medical device called PALACOS® fast R+G, a radiopaque bone cement with gentamicin. It includes details about the device's classification, indications for use, and a comparison to a predicate device.

However, the document does not contain any information about a study proving the device meets acceptance criteria in the context of an AI/ML medical device. The "Discussion of preclinical tests" section refers to performance testing of the bone cement's physical and chemical properties (e.g., compressive strength, bending strength, bacterial endotoxins), and states that "All obtained data fulfill the pre-defined acceptance criteria." This is for a traditional medical device (bone cement), not an AI/ML product. The document explicitly states "No clinical data was provided."

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI/ML device meets those criteria based solely on the provided text. The questions about sample size, data provenance, expert ground truth establishment, MRMC studies, standalone performance, and training set details are all relevant to AI/ML device validation, but this document is not about an AI/ML device.

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PALACOS ® MV is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.

PALACOS® MV is an acrylic bone cement for use in orthopedic surgery. It is formed from powder and liquid by exothermic polymerization. It secures the fixation of the grafted artificial joint, improving the transfer of forces at the interface implant - bone. It is currently marketed in a 44 g packaging size in the United States.

The provided document is a 510(k) summary for a medical device called PALACOS® MV, which is a polymethylmethacrylate (PMMA) bone cement. This document details the device's characteristics and its substantial equivalence to a predicate device, but does not describe "acceptance criteria" or a "study that proves the device meets the acceptance criteria" in the context of an AI/ML medical device.

The information requested in the prompt (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is typically associated with the rigorous validation of AI/ML-based medical devices for regulatory clearance. Since PALACOS® MV is a physical bone cement, these types of evaluations are not applicable.

Instead, the document focuses on demonstrating the substantial equivalence of PALACOS® MV to a previously cleared predicate device (Palamed®, K030904) through preclinical testing of its physical and mechanical properties. The "acceptance criteria" in this context would refer to the standards outlined in ISO 5833 and Heraeus's internal final test requirements, which the device met.

Here's an attempt to answer the questions based on the provided text, while highlighting the irrelevance of some questions to this type of device:

1. A table of acceptance criteria and the reported device performance

   Acceptance Criteria (Standards Met)	Reported Device Performance (PALACOS® MV)
   ISO 5833	Doughing time, maximum temperature, setting time, intrusion, compressive strength, bending modulus, and 4-point bending strength were characterized. Met ISO 5833 standards.
   Heraeus final test requirements	Tested for impact and bending strength (Dynstat test method). Met Heraeus final test requirements.
   ANSI/AAMI ST72:2011 (Bacterial Endotoxin Test)	Bacterial endotoxin evaluated (LAL test). Test results met endotoxin limits (20 endotoxin units (EU)/Device).
   Stability/Shelf Life	Data compared between subject and predicate devices. No specific quantitative criteria or results are detailed beyond "data were also compared".

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   The document does not explicitly state the sample sizes for the preclinical tests conducted to characterize the physical and mechanical properties of the bone cement. The tests were presumably conducted in a laboratory setting, likely in Germany, where Heraeus Medical GmbH is located. This would be considered prospective controlled laboratory testing, not data provenance in the AI/ML sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   Not applicable. "Ground truth" in the context of expert consensus (e.g., for image interpretation) is not relevant for evaluating the physical properties of bone cement. The "ground truth" for bone cement performance is based on established engineering and materials science principles, and international standards (like ISO 5833).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   Not applicable. Adjudication methods are used to resolve disagreements among human reviewers of data, particularly in complex medical image interpretation or clinical outcomes. This is not
   relevant for standardized mechanical and chemical testing of a material.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

   Not applicable. MRMC studies are used to evaluate the impact of an AI algorithm on human reader performance, typically in diagnostic tasks. This device is a physical bone cement, not an AI/ML algorithm, so an MRMC study was not performed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

   Not applicable. The concept of "standalone performance" refers to the evaluation of an AI algorithm independent of human interaction. PALACOS® MV is a physical product. Its performance is evaluated through material science tests, not as an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   The "ground truth" for the performance of PALACOS® MV is based on objective measurements and established international standards for bone cement (e.g., ISO 5833) and bacterial endotoxin testing (ANSI/AAMI ST72:2011). This is material science and chemistry, not clinical "outcomes data" or "pathology" in the diagnostic sense.

8. The sample size for the training set

   Not applicable. As a physical product, there is no "training set" in the context of AI/ML. The device's properties are inherent to its formulation and manufacturing process, evaluated through testing.

9. How the ground truth for the training set was established

   Not applicable, as there is no "training set" for this device.

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